Alembic Pharmaceuticals gets USFDA nod for generic anti-epileptic drug

New Delhi, Dec 20 (PTI) Alembic Pharmaceuticals Ltd on Friday said it has received final approval from the US health regulator for its generic Divalproex Sodium delayed-release capsules, used in the treatment of epilepsy.
     The approval granted by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) of Divalproex Sodium delayed-release capsules of strength 125 mg, Alembic Pharmaceuticals said in a regulatory filing.
     The approved ANDA is therapeutically equivalent to the Reference Listed Drug product (RLD), Depakote Sprinkle capsules, 125 mg of AbbVie Inc, it added.
     Divalproex Sodium is an anti-epileptic drug indicated for monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures, it added.
     Citing IQVIA data, the company said Divalproex Sodium delayed-release capsules 125 mg have an estimated market size of USD 61.1 million for 12 months ended September 2024.

(This story has not been edited by THE WEEK and is auto-generated from PTI)